Flow control plug securement

ABSTRACT

A catheter system may include a luer adapter, which may include an outer surface having threading or a recess. The catheter system may also include a flow control plug, which may include a proximal end and a distal end. The proximal end of the flow control plug may include a filter element permeable to air and not to blood. The distal end of the flow control plug may include a cylinder and a taper-shaped luer tip spaced apart from the cylinder. An inner surface of the cylinder may include a protrusion engaged in a snap-fit with the recess or corresponding threading mated with the threading.

BACKGROUND OF THE INVENTION

Infusion therapy is one of the most common health care procedures.Hospitalized, home care, and other patients receive fluids,pharmaceuticals, and blood products via a vascular access deviceinserted into the vascular system. Infusion therapy may be used to treatan infection, provide anesthesia or analgesia, provide nutritionalsupport, treat cancerous growths, maintain blood pressure and heartrhythm, or many other clinically significant uses.

Infusion therapy is facilitated by a vascular access device. Thevascular access device may access a patient's peripheral or centralvasculature. The vascular access device may be indwelling for short term(days), moderate term (weeks), or long term (months to years). Thevascular access device may be used for continuous infusion therapy orfor intermittent therapy.

A common vascular access device is a catheter that is inserted into apatient's vein. The catheter length may vary from a few centimeters forperipheral access to many centimeters for central access. The cathetermay be inserted transcutaneously or may be surgically implanted beneaththe patient's skin. The catheter may have a single lumen or multiplelumens for infusion of many fluids simultaneously.

One example of a catheter system that includes a catheter is the BDNEXIVA™ Closed IV (intravenous) Catheter System, by Becton, Dickinsonand Company. This system includes an over-the-needle, peripheralintravascular catheter, integrated extension tubing, a Y-adapter, aslide clamp, a flow control plug, a Luer access port, and a passiveneedle-shielding mechanism.

The design of the BD NEXIVA™ IV Catheter System can be described as aclosed system since it protects clinicians or operators from bloodexposure during the catheter insertion procedure. Since the needle iswithdrawn through a septum that seals, after the needle has been removedand both ports of the Y-adapter are closed, blood is contained withinthe NEXIVA™ device during catheter insertion. The pressure exerted onthe needle as it passes through the septum wipes blood from the needle,further reducing potential blood exposure. The clamp on the integratedextension tubing is provided to eliminate blood exposure when the flowcontrol plug is replaced with another vascular access device such as aninfusion set connection or a Luer access port.

A current procedure of initiating the use of a catheter system such asthe BD NEXIVA™ Closed IV Catheter System is as follows. A deviceoperator will insert the needle into the vasculature of a patient andwait for flashback of blood to travel into the device to confirm thatthe needle is properly located within the vasculature of the patient.The blood travels into and along the catheter of the device because aflow control plug permits air to escape the device as blood enters thedevice. In some instances, after an operator confirms proper placement,the operator may clamp the catheter system to halt the progression ofblood through the catheter system, remove the flow control plug, replacethe flow control plug with another vascular access device such as aninfusion set connection or a Luer access port, unclamp the cathetersystem, flush the blood from the catheter system back into thevasculature of the patient, and re-clamp the catheter system.

BRIEF SUMMARY OF THE INVENTION

The present disclosure relates generally to a flow control plug andrelated devices, systems, and methods. In some embodiments, the flowcontrol plug may be secured to a luer adapter of a catheter system in asecure manner, which may prevent accidental uncoupling of the flowcontrol plug from the luer adapter prior to use. If the flow controlplug prematurely uncouples from the luer adapter, contamination of theflow control plug may result, making the flow control plug unable to beused. In some embodiments, the flow control plug may also be secured tothe luer adapter in a fluid-tight manner, which may importantly preventleakage of fluid from the catheter system. In some embodiments, the flowcontrol plug may also include one or more features that facilitateattachment of the flow control plug to the luer adapter during assemblyor prior to use, including, for example, grip elements and/or flexiblearms. In some embodiments, the flow control plug may include one or morefeatures that reduce an axial force and torque necessary to make aconnection between the flow control plug and the luer adapter.

As used in the present disclosure, the term “distal” refers to a portionof the IV catheter system or component thereof that is farther from auser, and the term “proximal” refers to a portion of the IV cathetersystem or component thereof that is closer to the user. As used in thepresent disclosure, the term “user” may refer to a clinician, doctor,nurse, or any other care provider and may include support personnel.

In some embodiments, the catheter system may include one or more of thefollowing: a catheter adapter, a catheter extending distally from thecatheter adapter, a needle extending through the catheter and beyond adistal tip of the catheter when the needle is in an insertion position,the luer adapter, extension tubing, and the flow control plug. In someembodiments, the catheter adapter may include a side port, which may becoupled to the extension tubing. In some embodiments, the catheteradapter may include a septum, which may be disposed in a needle channelthrough which the needle travels in response to being retracted. In someembodiments, a fluid pathway of the catheter adapter may include one ormore of the following: a lumen of the catheter adapter distal to theseptum, the side port, the extension tubing, and the luer adapter. Insome embodiments, the luer adapter may be connectable to anothervascular access device, such as blood withdrawal and/or infusion means.

In some embodiments, the catheter system may include an intravenous (IV)catheter system. In some embodiments, the catheter system may include anintegrated or a closed catheter system, such as, for example, the BDNEXIVA™ Closed IV Catheter System, the BD NEXIVA™ DIFFUSICS™ Closed IVCatheter System, the BD SAF-T-INTIMA™ Closed IV Catheter System, or theBecton Dickinson PEGASUS™ Safety Closed IV Catheter System.

In some embodiments, the luer adapter may include a single port adapter,a dual port adapter, a Y-adapter, or another suitable type of lueradapter. In some embodiments, the luer adapter may include an outersurface, which may include a recess. In some embodiments, the lueradapter may be coupled to a catheter adapter via extension tubing. Insome embodiments, the catheter system may include a flow control plug,which may include a proximal end and a distal end. In some embodiments,the proximal end of the flow control plug may include a filter element,which may be permeable to air and not permeable to blood. In someembodiments, the distal end of the flow control plug may include acylinder and a taper-shaped luer tip spaced apart from the cylinder.

In some embodiments, an inner surface of the cylinder may include aprotrusion engaged in a snap-fit with the recess, which may secure theflow control plug to the luer adapter. In some embodiments, the outersurface of the luer adapter may include threading. In some embodiments,the distal end of the flow control plug may include correspondingthreading, which may be mated with the threading to secure the flowcontrol plug to the luer adapter.

In some embodiments, the cylinder may include multiple slots, which mayform multiple arms of the cylinder. The arms may be disposed between theslots. In some embodiments, the slots may extend through the cylinder.In some embodiments, an inner surface of one of the arms may include theprotrusion. In some embodiments, multiple of the arms may each includeanother protrusion, which may engage in a snap-fit with the recess orwith another recess in the outer surface of the luer adapter. Forexample, the slots may include a first slot and a second slot, and thearms may include a first arm and a second arm. In some embodiments, thefirst slot and the second slot may be disposed between the first arm andthe second arm. In some embodiments, an inner surface of the first armmay include the protrusion. In some embodiments, an inner surface of thesecond arm may include another protrusion. In some embodiments, theother protrusion may be engaged in a snap-fit with the recess or withanother recess of the outer surface of the luer adapter.

In some embodiments, the distal end may include a stepped surface. Insome embodiments, the distal end may extend outwardly from the proximalend to form the stepped surface. In some embodiments, the slots mayextend through the stepped surface. In some embodiments, the steppedsurface may be annular.

In some embodiments, an outer surface of the cylinder may include one ormore first grip elements. For example, outer surfaces of one or more ofthe arms may include one or more first grip elements. In someembodiments, the first grip elements may include ribs, which may beoriented longitudinally with respect to the flow control plug. In someembodiments, an outer surface of the proximal end may include one ormore second grip elements. In some embodiments, the second grip elementsmay include ribs, which may be oriented longitudinally with respect tothe flow control plug. In some embodiments, the cylinder may include afirst number of the first grip elements and/or the outer surface of theproximal end may include a second number of the second grip elements. Insome embodiments, the second number may be greater than the firstnumber. In some embodiments, a width of each of the first grip elementsmay be greater than a width of each of the second grip elements.

In some embodiments, a method of securing the flow control plug to thecatheter system for shipment may include providing the catheter systemand/or coupling the flow control plug to the luer adapter of thecatheter system before shipping the catheter system to a destination. Insome embodiments, coupling the flow control plug to the luer adapter ofthe catheter system before shipping the catheter system to thedestination includes engaging the recess with the protrusion in asnap-fit or mating the threading to the corresponding threading.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory and arenot restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

Example embodiments will be described and explained with additionalspecificity and detail through the use of the accompanying drawings inwhich:

FIG. 1 is an upper perspective view of an example catheter system,according to some embodiments;

FIG. 2A is an upper perspective view of an example threaded lueradapter, according to some embodiments;

FIG. 2B is a top view of the threaded luer adapter of FIG. 2A, accordingto some embodiments;

FIG. 2C is a side view of the threaded luer adapter of FIG. 2A,according to some embodiments;

FIG. 2D is a cross-sectional view of the threaded luer adapter of FIG.2A, along the line 2D-2D of FIG. 2C, according to some embodiments;

FIG. 2E is a proximal end view of the threaded luer adapter of FIG. 2A,according to some embodiments;

FIG. 3A is an upper perspective view of an example threaded flow controlplug, according to some embodiments;

FIG. 3B is a top view the threaded flow control plug of FIG. 3A,according to some embodiments;

FIG. 3C is a cross-sectional view of the threaded flow control plug ofFIG. 3A, along the line 3C-3C of FIG. 3B, according to some embodiments;

FIG. 4A is an upper perspective view of the threaded luer adapter ofFIG. 2A coupled to the threaded flow control plug of FIG. 3A, accordingto some embodiments;

FIG. 4B is a top view of the threaded luer adapter of FIG. 2A coupled tothe threaded flow control plug of FIG. 3A, according to someembodiments;

FIG. 4C is a cross-sectional view, along the line 4C-4C of FIG. 4B, ofthe threaded luer adapter of FIG. 2A coupled to the threaded flowcontrol plug of FIG. 3A, according to some embodiments;

FIG. 4D is a side view of the threaded luer adapter of FIG. 2A coupledto the threaded flow control plug of FIG. 3A, according to someembodiments;

FIG. 5A is an upper perspective view of another flow control plug,according to some embodiments;

FIG. 5B is a top view of the flow control plug of FIG. 5A, according tosome embodiments;

FIG. 5C is a cross-sectional view of the flow control plug of FIG. 5A,along the line 5C-5C of FIG. 5B, according to some embodiments;

FIG. 6A is an upper perspective view of the flow control plug of FIG. 5Acoupled with another luer adapter, according to some embodiments;

FIG. 6B is a top view of the flow control plug of FIG. 5A coupled withthe other luer adapter of FIG. 6A, according to some embodiments;

FIG. 6C is a cross-sectional view, along the line 6C-6C of FIG. 6B, ofthe flow control plug of FIG. 5A coupled with the other luer adapter ofFIG. 6A, according to some embodiments;

FIG. 6D is a side view of the flow control plug of FIG. 5A coupled withthe other luer adapter of FIG. 6A, according to some embodiments;

FIG. 7A is an upper perspective view another example flow control plug,according to some embodiments;

FIG. 7B is a top view of the flow control plug of FIG. 7A, according tosome embodiments;

FIG. 7C is a cross-sectional view of the flow control plug of FIG. 7A,along line 7C-7C of FIG. 7B, according to some embodiments;

FIG. 7D is a side view of the flow control plug of FIG. 7A, according tosome embodiments;

FIG. 8A is an upper perspective view of the flow control plug of FIG. 7Acoupled with the other luer adapter of FIG. 6A, according to someembodiments;

FIG. 8B is a top view of the flow control plug of FIG. 7A coupled withthe other luer adapter of FIG. 6A, according to some embodiments;

FIG. 8C is a cross-sectional view, along the line 8C-8C of FIG. 8B, ofthe flow control plug of FIG. 7A coupled with the other luer adapter ofFIG. 6A, according to some embodiments; and

FIG. 8D is a side view of the flow control plug of FIG. 7A coupled withthe other luer adapter of FIG. 6A, according to some embodiments.

DETAILED DESCRIPTION OF THE INVENTION

The presently preferred embodiments of the present invention will bebest understood by reference to the drawings, wherein like referencenumbers indicate identical or functionally similar elements. It will bereadily understood that the components of the present invention, asgenerally described and illustrated in the figures herein, could bearranged and designed in a wide variety of different configurations.Thus, the following more detailed description, as represented in thefigures, is not intended to limit the scope of the invention as claimed,but is merely representative of presently preferred embodiments of theinvention.

Referring now to FIG. 1, a catheter system 10, such as, for example, theBD NEXIVA™ Closed IV (intravenous) Catheter System, by Becton, Dickinsonand Company, is used to communicate fluid with the vascular system of apatient. An example of the catheter system 10, as shown in FIG. 1,includes an introducer needle 12; an over-the-needle, peripheralintravascular catheter 14 made from polyurethane; an integratedextension tubing 16 with a Y-adapter 18 and slide clamp 20; a flowcontrol plug 22; a Luer access port 24; a passive needle-shieldingmechanism 26; and a catheter adapter 28 from which the catheter 14extends. In some embodiments, any adapter used to connect two or morevascular access devices may be used in place of the Y-adapter 18.

The catheter system 10 is a closed system since it protects a user fromblood exposure during the catheter 14 insertion procedure. Since theneedle 12 is withdrawn through a septum that seals after the needle 12has been removed and both ports of the Y-adapter 18 are closed, blood iscontained within the catheter system 10 during catheter 14 insertion.The pressure exerted on the needle 12 as it passes through the septumwipes blood from the needle 12, further reducing potential bloodexposure. The slide clamp 20 on the integrated extension tubing 16 isprovided to eliminate blood exposure when the flow control plug 22 isreplaced with another vascular access device such as an infusion setconnection or another Luer access port 24.

As mentioned above, a current procedure of initiating the use of theextravascular system 10 is as follows. The user may insert the needle 12into the vasculature of a patient and wait for flashback of blood totravel into the catheter system 10 to confirm that the needle 12 isproperly located within the vasculature of the patient. The bloodtravels into and along the catheter 14 in the space between the needle12 and the catheter 14. This occurs because a flow control plug 22permits air to escape the catheter system 10 as blood enters thecatheter system 10. After an operator confirms proper placement, andafter adequate venting of the catheter system 10 has occurred, the usermay clamp extension tubing 16 to halt the progression of blood throughthe catheter 14, remove the flow control plug 22, replace the flowcontrol plug 22 with another vascular access device such as an infusionset connection or a Luer access port similar or identical to Luer accessport 24. In some instances, the user may then unclamp the extensiontubing 16, flush the blood from the catheter 14 back into thevasculature of the patient, and re-clamp the extension tubing 16.Alternate flow control plugs, luer adapters, and venting procedures aredesired and will be discussed with reference to the figures followingFIG. 1.

Referring now to FIG. 2A-2E, an example Y-adapter 30 of the cathetersystem 10 is illustrated, according to some embodiments. In someembodiments, any adapter used to connect two or more vascular accessdevices may be used in place of the Y-adapter 30. As illustrated inFIGS. 2A-2E, in some embodiments, an outer surface of the Y-adapter 30may include one or more threads 32. In some embodiments, a second portof the Y-adapter 30 may include the outer surface having the threads 32.Thus, in some embodiments, both the Luer access port 24 and the secondport of the Y-adapter may be threaded.

Referring now to FIG. 3A-3C, the catheter system 10 may include a flowcontrol plug 34, which may be configured to couple to the Y-adapter 30,for example. In some embodiments, the flow control plug 34 may beremovably coupled to the Y-adapter 30. In some embodiments, the flowcontrol plug 34 may include a proximal end 36 and a distal end 38. Insome embodiments, the proximal end 36 of the flow control plug, whichmay include a venting or filter element 40. In some embodiments, thefilter element 40 may be gas permeable. In some embodiments, the filterelement 40 may be permeable to air and not permeable to blood. In someembodiments, the distal end 38 may include a luer-lock portion, whichmay include a cylinder 42, although the luer-lock portion may also begenerally cylindrical in some embodiments. In some embodiments, thedistal end 38 may include the cylinder 42 and a taper-shaped luer tip 44spaced apart from the cylinder 42.

In some embodiments, the cylinder 42 and the luer tip 44 may be sizedand configured to connect to a female luer fitting. In some embodiments,the luer tip 44 may extend distal to a distal end of the cylinder 42. Insome embodiments, an inner surface of the cylinder 42 may include one ormore corresponding threads 46, which may be mated with the threads 32 tosecure the flow control plug 34 to the Y-adapter 30. In someembodiments, the distal end 38 may include a stepped surface 48. In someembodiments, the distal end 38 may extend outwardly from the proximalend 36 to form the stepped surface 48. In some embodiments, the steppedsurface 48 may be annular.

In some embodiments, an outer surface of the cylinder 42 may include oneor more first grip elements 50. In some embodiments, the first gripelements 50 may include ribs, which may be oriented longitudinally withrespect to the flow control plug 34, as illustrated in FIGS. 3A-3B. Insome embodiments, the first grip elements 50 may extend from the steppedsurface 48. In some embodiments, the first grip elements 50 may extendalong an entire length of the cylinder 42, as illustrated, for example,in FIGS. 3A-3B, which may facilitate gripping of the distal end 38 bythe user. In some embodiments, the first grip elements 50 may extendalong a portion of a length of the cylinder 42.

In some embodiments, an outer surface of the proximal end 36 may includeone or more second grip elements 52. In some embodiments, the secondgrip elements 52 may include ribs, which may be oriented longitudinallywith respect to the flow control plug 34. In some embodiments, thecylinder 42 may include a first number of the first grip elements 50and/or the outer surface of the proximal end 36 may include a secondnumber of the second grip elements 52. In some embodiments, the secondnumber may be greater than the first number. In some embodiments, havinga greater number of second grip elements 52 than first grip elements 50may facilitate placement of a palm of a hand of the user around theproximal end 36 while a thumb of the hand is placed on the distal end 38during coupling and/or uncoupling of the Y-adapter 30 and the flowcontrol plug 34. In some embodiments, the proximal end 36 may include 6to 8 second grip elements 52, which may be spaced apart around acircumference of the proximal end 36. In some embodiments, a width ofeach of the first grip elements 50 may be greater than a width of eachof the second grip elements 52, which may facilitate gripping by thethumb. In some embodiments, the first grip elements 50 may oppose eachother, as illustrated, for example, in FIG. 3C, which may facilitategripping of the distal end 38 by the thumb of the user.

In some embodiments, the filter element 40 may include a filter paper.In some embodiments, the filter element 40 may include an acryliccopolymer membrane cast on a nonwoven nylon support. In these and otherembodiments, the filter element 40 may include a VERSAPOR™ 800R membraneor another suitable membrane. In some embodiments, the filter element 40may be oleophobic and/or hydrophobic material. In some embodiments, thefilter element may not leak water when subjected to 5 psi minimum waterpressure for 10 seconds. In some embodiments, a rate of air flow throughthe filter element 40 may be between 5 cc/min and 50 cc/min whensubjected to 0.1 psi or 1.0 psi air pressure. In some embodiments, thefilter element 40 may be attached to the proximal end of the flowcontrol plug 34.

In some embodiments, the flow control plug 34 may be sterilized andcoupled to the Y-adapter 30. The catheter system 10, including the flowcontrol plug 34 coupled to the Y-adapter 30, may then be packaged andshipped to a destination, such as, for example, a hospital, clinic, orother facility. In some embodiments, securement of the flow control plug34 to the Y-adapter 30 as outlined in the present disclosure may preventthe flow control plug 34 from loosening and/or falling off the Y-adapter30 during shipment, which might otherwise occur due to due to aging orunsecure attachment of the flow control plug 34 to the Y-adapter 30. Insome embodiments, securement of the flow control plug 34 to theY-adapter 30 as outlined in the present disclosure may avoid prematureuncoupling of the flow control plug 34 from the Y-adapter 30 andsubsequent contamination of the flow control plug, making the flowcontrol plug unable to be used.

In some embodiments, the flow control plug 34 may be constructed of oneor more plastic materials such as, for example, polycarbonate,polypropylene, polyethylene, glycol-modified polyethylene terephthalate,acrylonitrile butadiene styrene, or any other moldable plastic materialused in medical devices. In some embodiments, the flow control plug 34may have a melting temperature of 130° C. In some embodiments, the flowcontrol plug 34 may be compliant with ISO 594-1.

Referring now to FIGS. 4A-4D, in some embodiments, the threads 32 of theY-adapter 30 may be mated with the corresponding threads 46 of the flowcontrol plug 34 to secure the flow control plug 34 to the Y-adapter 30.In some embodiments, a maximum outer diameter of the distal end 38 orcylinder 42 may be greater than a maximum diameter of the proximal end36 (which may include the second grip elements 52 protruding from asurface of the proximal end), which may facilitate gripping of the flowcontrol plug 34 by the user. In some embodiments, the proximal end 36may be generally cylindrical. In some embodiments, the proximal end 36may be tapered, as illustrated, for example, in FIG. 4C.

Referring now to FIGS. 5A-5C, in some embodiments, the cylinder 42 ofanother flow control plug 54 may include an inner surface having one ormore protrusions 56, which may engage in a snap-fit with anotherY-adapter, such as, for example, the Y-adapter 54 illustrated in FIGS.6A-6C. The protrusions 56 may include various shapes and sizes. In someembodiments, the inner surface of the cylinder 42 may include one ormore annular protrusions 56. In some embodiments, the protrusions 56 mayinclude ribs or flanges. In some embodiments, the flow control plug 54may include or correspond to the flow control plug 34 of FIGS. 3-4. Infurther detail, in some embodiments, the flow control plug 54 mayinclude one or more features of the flow control plug 34. For example,the flow control plug 54 may include the first grip elements 50 and/orthe second grip elements 52. As another example, the proximal end 36 ofthe flow control plug 54 may include the filter element 40.

Referring now to FIGS. 6A-6D, in some embodiments, in some embodiments,the protrusions 56 may engage in a snap-fit with one or more recesses 60of a Y-adapter 58, securing the flow control plug 54 to the Y-adapter58. In some embodiments, the recesses 60 may include various shapes andsizes configured to receive the protrusions 56 in a snap-fit. In someembodiments, the recesses 60 may each include a groove. In someembodiments, a particular recess 60 may be formed by a ridge or flangeand may receive one or more particular protrusions 56 in a snap-fit. Insome embodiments, the ridge may be annular. In some embodiments, theflow control plug 34 may be removably coupled to the Y-adapter 58 suchthat the snap-fit may be undone.

Referring now to FIGS. 7A-7D, in some embodiments, the cylinder 42 ofanother flow control plug 62 may include one or more slots 64, which mayform multiple arms 66 of the cylinder 42. The arms 66 may be disposedbetween the slots 64. In some embodiments, the slots 64 may extend atleast partially through the cylinder 42. In some embodiments, the slots64 may be generally aligned with a longitudinal axis of the flow controlplug 62. In some embodiments, each of the arms 66 may form a curvedportion of a wall of the cylinder 42. In some embodiments, the steppedsurface 48 may be divided into multiple sections by the slots 66.

In some embodiments, the slots 64 and the arms 66 may facilitateengagement of the protrusions 56 and the recesses 60 in a snap-fit asthe arms 66 bias outwardly when the flow control plug is moved towardsthe Y-adapter, allowing the protrusions 56 to more easily access therecesses 60. In some embodiments, the slots 64 may not extend throughthe stepped surface 48. In some embodiments, the slots 64 may extendthrough the stepped surface 48 and be proximate the proximal end 36,which may allow the arms 66 to bias outwardly more easily when the flowcontrol plug 62 is being coupled to the Y-adapter 58. In someembodiments, the slots 64 may reduce a force necessary to engage theprotrusions 56 and the recesses 60 in a snap-fit. In some embodiments,ends of the protrusion 56 may be spaced apart from edges of theparticular arm 66 on which the protrusion 56 is disposed, giving theprotrusion 56 a length that may reduce a force necessary to remove theflow control plug 54 from the Y-adapter 54 and/or couple the flowcontrol plug 54 to the Y-adapter 54.

In some embodiments, the flow control plug 62 may include or correspondto the flow control plug 34 of FIGS. 3-4 and/or the flow control plug 54of FIGS. 5-6. In further detail, in some embodiments, the flow controlplug 62 may include one or more features of the flow control plug 54and/or the flow control plug 34. For example, the flow control plug 62may include the first grip elements 50 and/or the second grip elements52. As another example, the proximal end 36 of the flow control plug 62may include the filter element 40. Also, the flow control plug 34 and/orthe flow control plug 54 may include one or more features of the flowcontrol plug 62.

In some embodiments, an inner surface of one or more of the arms 66 mayinclude a particular protrusion 56, which may engage in a snap-fit witha particular recess 60. In some embodiments, the distal end 38 mayinclude a first slot 64 a and a second slot 64 b (which may be referredto herein collectively as “slots 64”), and the arms 66 may include afirst arm 66 a and a second arm 66 b (which may be referred to hereincollectively as “arms 66”), as illustrated, for example, in FIG. 7A. Insome embodiments, the first slot 64 a and the second slot 64 b may bedisposed between the first arm 66 a and the second arm 66 b. In someembodiments, the stepped surface 66 a may be proximate the first arm 66a and/or the stepped surface 66 b may be proximate the second arm 66 a,as illustrated, for example, in FIG. 7A.

In some embodiments, an inner surface of the first arm 66 a may includea first protrusion 56. In some embodiments, an inner surface of thesecond arm 66 b may include a second protrusion 56. In some embodiments,the first protrusion 56 may oppose the second protrusion 56. In someembodiments, the first and second protrusions 56 may be engaged in asnap-fit with a single recess 60 or with multiple recesses 60 disposedon the outer surface of the Y-adapter 58.

Referring now to FIGS. 8A-8D, in some embodiments, the protrusions 56may engage in a snap-fit with one or more recesses 60 of the Y-adapter58, securing the flow control plug 54 to the Y-adapter 58. In someembodiments, any adapter may be used to connect two or more vascularaccess devices may be used in place of the Y-adapter 58. It isunderstood that in some embodiments, the inner surface of the cylinder42 or the inner surface of the arms 66 may include one or more recesses60, while the outer surface of the Y-adapter 58 may include one or moreprotrusions 56.

In some embodiments, the flow control plug 54 and/or the flow controlplug 62 may be sterilized and coupled to the Y-adapter 58. The cathetersystem 10, including the flow control plug 54 or the flow control plug62 coupled to the Y-adapter 58, may then be packaged and shipped to adestination, such as, for example, a hospital, clinic, or otherfacility. In some embodiments, securement of the flow control plug 54and/or the flow control plug 62 to the Y-adapter 58 as outlined in thepresent disclosure may prevent the flow control plug 54 and/or the flowcontrol plug 62 from loosening and/or falling off the Y-adapter 58during shipment, which might otherwise occur due to due to aging orunsecure attachment of the flow control plug 54 and/or the flow controlplug 62 to the Y-adapter 58.

In some embodiments, a method of securing a flow control plug to acatheter system for shipment may include providing the catheter system.In some embodiments, the method may include sterilizing and/or couplingthe flow control plug to a luer adapter of the catheter system beforeshipping the catheter system to a destination. In some embodiments,coupling the flow control plug to the luer adapter of the cathetersystem before shipping the catheter system to the destination includesengaging the recess with the protrusion in a snap-fit or mating thethreading to the corresponding threading.

The present invention may be embodied in other specific forms withoutdeparting from its structures, methods, or other essentialcharacteristics as broadly described herein and claimed hereinafter. Thedescribed embodiments and examples are to be considered in all respectsonly as illustrative, and not restrictive. The scope of the inventionis, therefore, indicated by the appended claims, rather than by theforegoing description. All changes that come within the meaning andrange of equivalency of the claims are to be embraced within theirscope.

All examples and conditional language recited herein are intended forpedagogical objects to aid the reader in understanding the invention andthe concepts contributed by the inventor to furthering the art, and areto be construed as being without limitation to such specifically recitedexamples and conditions. Although implementations of the presentinventions have been described in detail, it should be understood thatthe various changes, substitutions, and alterations could be made heretowithout departing from the spirit and scope of the invention.

1. A catheter system, comprising: a luer adapter, comprising an outersurface having a recess, wherein the luer adapter is coupled to acatheter adapter via extension tubing; a flow control plug, comprising:a proximal end having a filter element permeable to air and not toblood; and a distal end having a cylinder and a taper-shaped luer tipspaced apart from the cylinder, wherein an inner surface of the cylinderincludes a protrusion engaged in a snap-fit with the recess.
 2. Thecatheter system of claim 1, wherein the cylinder comprises a pluralityof slots forming a plurality of arms disposed between the plurality ofslots, wherein an inner surface of an arm of the plurality of armsincludes the protrusion.
 3. The catheter system of claim 2, wherein theplurality of slots extend through the cylinder.
 4. The catheter systemof claim 2, wherein the plurality of slots includes a first slot and asecond slot, wherein the plurality of arms includes a first arm and asecond arm, wherein the first slot and the second slot are each disposedbetween the first arm and the second arm, wherein an inner surface ofthe first arm includes the protrusion, wherein an inner surface of thesecond arm includes another protrusion, wherein the other protrusion isengaged in a snap-fit with the recess or with another recess of theouter surface of the luer adapter.
 5. The catheter system of claim 2,wherein an outer surface of at least one of the plurality of armsincludes a grip element.
 6. The catheter system of claim 7, wherein thegrip element includes a rib oriented longitudinally with respect to theflow control plug.
 7. The catheter system of claim 1, wherein an outersurface of the proximal end includes a plurality of grip elements. 8.The catheter system of claim 7, wherein the plurality of grip elementsincludes ribs oriented longitudinally with respect to the flow controlplug.
 9. The catheter system of claim 1, wherein the distal end furthercomprises a stepped surface, wherein the distal end extends outwardlyfrom the proximal end to form the stepped surface.
 10. The cathetersystem of claim 9, wherein the cylinder comprises a plurality of armsand a plurality of slots disposed between the plurality of arms, whereinthe plurality of slots extend through the stepped surface.
 11. Thecatheter system of claim 1, wherein the luer adapter is a Y-adapter. 12.A catheter system, comprising: a luer adapter comprising an outersurface having threading, wherein the luer adapter is coupled to acatheter adapter via extension tubing; a flow control plug, comprising:a proximal end having a filter element permeable to air and not toblood; and a distal end having a cylinder and a taper-shaped luer tipspaced apart from the cylinder, wherein an inner surface of the cylinderincludes corresponding threading, wherein the distal end furthercomprises a stepped surface, wherein the distal end extends outwardlyfrom the proximal end to form the stepped surface.
 13. The cathetersystem of claim 12, wherein an outer surface of the cylinder includes agrip element.
 14. The catheter system of claim 13, wherein the gripelement includes a rib oriented longitudinally with respect to the flowcontrol plug.
 15. The catheter system of claim 12, wherein an outersurface of the proximal end includes a plurality of grip elements. 16.The catheter system of claim 15, wherein the plurality of grip elementsincludes ribs oriented longitudinally with respect to the flow controlplug.
 17. The catheter system of claim 12, wherein an outer surface ofthe cylinder includes a plurality of ribs oriented longitudinally withrespect to the flow control plug, wherein an outer surface of theproximal end includes a plurality of other ribs oriented longitudinallywith respect to the flow control plug.
 18. The catheter system of claim17, wherein the cylinder includes a first number of the ribs and theouter surface of the proximal end includes a second number of the otherribs, wherein the second number is greater than the first number. 19.The catheter system of claim 17, wherein a width of each of theplurality of ribs is greater than a width of each of the plurality ofother ribs.
 20. A method of securing a flow control plug to a cathetersystem for shipment: providing a catheter system, wherein the cathetersystem comprises: a catheter adapter and a luer adapter coupled to thecatheter adapter via extension tubing, wherein the luer adapter includesan outer surface having threading or a recess; coupling a flow controlplug to the luer adapter of a catheter system before shipping thecatheter system to a destination, wherein the flow control plugcomprises: a proximal end having a filter element permeable to air andnot to blood; and a distal end having a cylinder and a taper-shaped luertip spaced apart from the cylinder, wherein an inner surface of thecylinder includes corresponding threading or a protrusion, whereincoupling the flow control plug to the luer adapter of the cathetersystem before shipping the catheter system to the destination comprisesengaging the recess with the protrusion in a snap-fit or mating thethreading to the corresponding threading.